Package leaflet: Information for the patient 102660/LF/046/02

Gentisone® HC Ear Drops

Gentamicin and Hydrocortisone acetate

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Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

-    Please keep this leaflet. You may need to read it again.

-    If you have any further questions, ask your doctor or pharmacist.

-    This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

-    If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1.    What Gentisone HC Ear Drops are and what they are used for

2.    What you need to know before you use Gentisone HC Ear Drops

3.    How to use Gentisone HC Ear Drops

4.    Possible side effects

5.    How to store Gentisone HC Ear Drops

6.    Contents of the pack and other information

1.    WHAT GENTISONE HC EAR DROPS ARE AND WHAT THEY ARE USED FOR

The name of your medicine is Gentisone HC Ear Drops. Gentisone HC Ear Drops contain the active ingredients gentamicin which belongs to a group of medicines called antibiotics and hydrocortisone acetate which is a steroid.

Gentisone HC Ear Drops are used in adults and children to treat eczema and bacterial infections in the external ear, to prevent infections in an injured ear and to treat infected bone cavities (mastoid) behind the ear after an operation.

2.    WHAT YOU NEED TO KNOW BEFORE YOU USE GENTISONE HC EAR DROPS

Do not take this medicine if you:

• Are allergic to gentamicin, hydrocortisone, any of the other ingredients of Gentisone HC Ear

Drops listed in section 6, or similar medicine containing an aminoglycoside antibiotic or steroid

•    Have or suspect you have a burst ear drum, if you are being treated for a problem with your external ear

•    Suffer from myasthenia gravis, a disease causing muscle weakness.

Warnings and precautions

Talk to your doctor or pharmacist before

using Gentisone HC Ear Drops if you:

•    Have any problems with your kidneys or liver

•    Are using this medicine for a long period of time

•    Have open wounds or damaged skin. If either of these applies to you or if you are not sure, tell your doctor.

Other medicines and Gentisone HC Ear Drops

Please tell your doctor if you are taking, have recently taken, or might take any other medicines including those obtained without a prescription.

Pregnancy and breastfeeding

Tell your doctor before being given Gentisone HC Ear Drops if you are pregnant, planning to become pregnant or if you are breastfeeding. Gentisone HC Ear Drops are not recommended for use in pregnancy or breastfeeding unless considered appropriate by your doctor. Driving and using machinery This medicine should not affect your ability to drive or use machines.

Gentisone HC Ear Drops contain Benzalkonium chloride

Irritant, may cause skin reactions.

3. HOW TO USE GENTISONE HC EAR DROPS

Always use the drops as your doctor or pharmacist tells you to. Check with your doctor or pharmacist if you are not sure. Shake the bottle and use 2-4 drops three to four times a day and at night. Alternatively wicks medicated with your medicine may be placed into the external ear or into the bone cavity behind your ear (mastoid).

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The drops should not be used continuously for a long time as it may irritate your skin. If your infection is severe, your doctor may also give you antibiotics by injection.

If you swallow your ear drops

If you or someone else, accidentally swallows some of this medicine, contact your doctor, pharmacist or nearest hospital emergency department immediately.

If you forget to use Gentisone HC Ear Drops

If you forget to use your drops, use your ■ next dose as soon as you remember and [ continue as before.

- 4. POSSIBLE SIDE EFFECTS

Like all medicines, Gentisone HC Ear Drops can cause side effects, although not everybody gets them.

If you notice:

•    Itching or skin rashes

•    Swelling of the face, lips or throat

•    Difficulty in breathing or wheeziness, stop using these drops and tell your doctor immediately. These may be signs of an allergic reaction.

Other side effects include:

•    Super infection (infection occurring after an earlier infection)

•    Hearing loss

•    Burning sensation

•    Stinging sensation

•    Itching at the site of administration. Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme website: www.mhra.gov.uk/yellowcard.

By reporting side effects you can help provide more information on the safety of this medicine.

5. HOW TO STORE GENTISONE HC EAR DROPS

Keep this medicine out of the sight and reach of children

Store your medicine in a safe place below 25°C and do not freeze or mix with other liquids.

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This medicine must not be used after the expiry date printed on the pack.

Do not use for more than 4 weeks after opening.

Return any unused drops to the pharmacist.

6. CONTENTS OF THE PACK AND OTHER INFORMATION What Gentisone HC Ear Drops contain

The ear drops contain the active ingredients gentamicin sulphate 0.3% w/v gentamicin base and 1.0% w/v hydrocortisone acetate.

The other ingredients are: benzalkonium chloride, povidone, polyethylene glycol 4000, sodium chloride, borax, disodium edetate and Water for injections.

What Gentisone HC Ear Drops look like and the contents of the pack

The ear drops are available as a white solution in 10ml dropper bottles.

Marketing Authorisation Holder and Manufacturer responsible for release:

Amdipharm UK Limited,

Capital House,

85 King William Street,

London EC4N 7BL,

UK

Alternative manufacturer responsible for release:

Famar S.A.,

Agiou Dimitriou 63, Alimos Attiki,

17456, Greece

Gentisone is the registered trade mark of Amdipharm Mercury International Limited.

This leaflet was last revised in November 2014.

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